Abstract
PurposeUse of novel medical technologies, such as leadless pacemaker (LP) therapy, may be subjected to a learning curve effect. The objective of the current study was to assess the impact of operators’ experience on the occurrence of serious adverse device effects (SADE) and procedural efficiency.MethodsPatients implanted with a Nanostim LP (Abbott, USA) within two prospective studies (i.e., LEADLESS ll IDE and Leadless Observational Study) were assessed. Patients were categorized into quartiles based on operator experience. Learning curve analysis included the comparison of SADE rates at 30 days post-implant per quartile and between patients in quartile 4 (> 10 implants) and patients in quartiles 1 through 3 (1–10 implants). Procedural efficiency was assessed based on procedure duration and repositioning attempts.ResultsNanostim LP implant was performed in 1439 patients by 171 implanters at 60 centers in 10 countries. A total of 91 (6.4%) patients experienced a SADE in the first 30 days. SADE rates dropped from 7.4 to 4.5% (p = 0.038) after more than 10 implants per operator. Total procedure duration decreased from 30.9 ± 19.1 min in quartile 1 to 21.6 ± 13.2 min (p < 0.001) in quartile 4. The need for multiple repositionings during the LP procedure reduced in quartile 4 (14.8%), compared to quartiles 1 (26.8%; p < 0.001), 2 (26.6%; p < 0.001), and 3 (20.4%; p = 0.03).ConclusionsLearning curves exist for Nanostim LP implantation. Procedure efficiency improved with increased operator experience, according to a decrease in the incidence of SADE, procedure duration, and repositioning attempts.
Highlights
Leadless pacemaker (LP) therapy was introduced to address the limitations of traditional transvenous implantable pacemakers (PM) [1]
The pooled cohort consisted of 952 patients from the Leadless ll IDE Study and 487 patients from the Leadless Observational Study, resulting in a total of 1439 patients who underwent a Nanostim LP implant performed by 171 implanters at 60 centers in 10 countries
In the initial phase of the LEADLESS Observational Trial, a right ventricular apical position was recommended; there were two instances of cardiac perforation that resulted in death which might partially be explained by the more penetrable right ventricular apex compared to the current recommended more apicoseptal positioning of the device
Summary
Leadless pacemaker (LP) therapy was introduced to address the limitations of traditional transvenous implantable pacemakers (PM) [1]. Reported short-term complication rates of LP therapy have been comparable to traditional PM therapy but were different in nature [2]. When interpreting these results, the expected learning curve associated with the implantation of a novel device using a unique set of tools must be considered. Procedure-related complications, such as cardiac injury, potentially relates to the novelty of the leadless technology and operator experience. As has been the case with other technologies, one can expect that the outcome and efficacy will improve with time and clinical experience
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